risk-analysis, DIN 14971, risk-management, medical-devices
Risko analysis, DIN 14971, Risk management Medical devices, In-Vitro-Diagnostics, IVD DEUTSCH | IMPRINT 14.05.2008 FDA notification, CE-marking, EN 1441 Qware Riskmanager
risk-analysis, DIN 14971, risk-management, medical-devices
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post production information implementation of risk management according to DIN EN 14971- Advantages
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Likelihood and severity evaluation after measuresPartner
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directive 93/42/EWG risk evaluation and for risk control
New functions in Qware Riskmanager 2.5
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Screenshots of Qware Riskmanager 2.5

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Definition of the risk diagramm

The risk diagram definition includes the definition of the elementary parameters of risk analysis which are likelihood, severity, and risk acceptance

Greybox

The greybox is a graphics tool for the alleviation of the functional analysis. With the help of this tool you can prepare a visual presentation of the functions and their respective dependencies for your planned product. Furthermore, you can indicate the input, output and disturbance variables. The greybox is the starting point of your risk analysis.

Risk analysis & -evalutaion

In the program part Analysis, you establish the structure of your risk analysis. The structure consists of the elements function, hazard, cause and measure. These four elements are connected in a tree structure.
Risk evaluation of each function-hazard-cause-combination is made prior and after the implementation of a measure.

Risk control

All measures to be carried out are managed in program part Risk control. Identical measures are combined in one measure and are identified by a new measure number. All data on this page always refer to the measure specified in list box Select measure.
Multiple controlling functions and the integrated dependency-checker facilitate to keep the overview even in very large projects.

Documentation

The program part documentation offers the possibility to print the results of your risk analysis or to export them to other formats like Microsoft Word, Microsoft Excel or PDF.

Print preview & data export

Every report can previously be viewed on a preview screen and has its own export functions. The subreports can be joined and printed or exported as a complete risk management dossier.
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